ZEPU-2000 Limb Rehabilitation Trainer Study (ZEPU2000RCT)

Conditions

• Incomplete Spinal Cord Injury (SCI)
• Lower Extremity Motor Dysfunction
• Stroke
• Traumatic Brain Injury
• Upper Extremity Motor Dysfunction

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• ZEPU-2000A — DEVICE
  An electromechanical upper limb rehabilitation system providing passive, active-assisted, and active-resisted movement training across the shoulder, elbow, and wrist. Integrated sensors record range of motion, movement speed, and torque, with software-guided protocols and real-time feedback. Administered 3 times weekly for 12 weeks in addition to standard rehabilitation.
• ZEPU-2000D — DEVICE
  A lower limb robotic trainer with actuated joints at the hip, knee, and ankle supporting repetitive stepping and weight-bearing training that simulates gait kinematics. Provides passive to active-assisted progression with force sensors and visual biofeedback on step length, cadence, and symmetry. Administered 3 times weekly for 12 weeks in addition to standard rehabilitation.
• ZEPU-2000E — DEVICE
  A multifunctional robotic system combining upper and lower limb training on a single platform, supporting task-oriented movements such as reaching-to-grasp, stepping, and sit-to-stand. Intelligent control adjusts support level in real time based on performance. Administered 3 times weekly for 12 weeks in addition to standard rehabilitation.
• Standard Rehabilitation Care — BEHAVIORAL
  Individualized conventional rehabilitation without robotic assistance, including therapist-led strengthening exercises, balance training, stretching, and gait retraining, delivered per institutional protocol throughout the 12-week study period.

Study Details

The goal of this clinical trial is to learn whether the ZEPU-2000A, ZEPU-2000D and ZEPU-2000E robotic rehabilitation trainers help people with weakness or movement problems in their arms and legs. These devices are used to guide repeated arm and leg movements as part of rehabilitation therapy. The study will also look at whether the devices are safe to use. The main questions it aims to answer are: Is training with the ZEPU-2000 devices safe, and how well do patients tolerate and stick with the training sessions? Does adding robotic training to usual rehabilitation improve muscle strength, joint movement, balance, walking, and daily function more than usual rehabilitation alone? Researchers will compare a group receiving robotic-assisted rehabilitation plus usual care to a group receiving usual rehabilitation care alone, to see whether the robotic devices provide added benefit. Participants will: Be adults aged 18-60 with arm and/or leg movement problems caused by stroke, incomplete spinal cord injury, traumatic brain injury, or an orthopedic condition Attend training sessions 3 times a week for 12 weeks (about 36 sessions total), each lasting approximately 45 minutes Undergo assessments of strength, movement, balance, and daily function at the start of the study and every 2 weeks throughout the 12-week period Be monitored for any side effects or safety concerns, such as skin irritation, falls, or discomfort, at every session

Key Dates

First listed

Aug 6, 2026

Start date

Aug 31, 2026

Status verified

Aug 2026

Primary completion

Oct 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

36 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Robotic-Augmented Rehabilitation Group
  Participants receive standard-of-care rehabilitation combined with robotic-assisted therapy using the ZEPU-2000A, ZEPU-2000D, or ZEPU-2000E upper and lower limb trainer systems. Robotic training is provided 3 times weekly for 12 weeks (approximately 36 sessions), each session lasting approximately 45 minutes and including warm-up, device set-up, structured passive/active-assisted/active training, and cool-down.
• Active Comparator: Usual Care Group
  Participants receive standard-of-care rehabilitation alone, including individualized rehabilitation and exercise (e.g., strengthening, balance training, stretching, gait retraining), without robotic-assisted therapy.

Primary Outcome Measure

Incidence of Device-Related Adverse Events and Serious Adverse Events [ Time Frame: Baseline (T=0) up to 12 weeks, assessed every 2 weeks ]

Central Contacts

• Md. Abdus Shakoor, Ph.D.
  +8801819410080
  [email protected]

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